eoadjuvant chemotherapy in patients with biliary tract carcinomas

Phase 1

• Conditions: Patients with resectable intra- or extrahepatic biliary tract carcinomas.; MedDRA version: 17.0Level: LLTClassification code 10025734Term: Malignant neoplasm of biliary tract, part unspecifiedSystem Organ Class: 100000004864; MedDRA version: 17.0Level: LLTClassification code 10028982Term: Neoplasm biliary tractSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002798-12-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-18
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Biliary tract carcinoma - cytologically or histologically verified or clinical/radiologically
- BTC which is considered to be resectable by the treating surgeon i.e. T1-3N0-1M0. The patient must be evaluated at the local HBP-MDT conference
- The patient is operable (i.e. no co-morbidity which can preclude anaesthesia or sur-gery)
- WHO performance status 0-1
- Age = 18 years
- Adequate haematological, renal, and hepatic function: WBC > 3.0 x 109/l, platelets > 100 x 109/l, creatinine <1.5 x UNL (Upper normal limit), bilirubin <3.0 x UNL, PP % 0,5 – 1,3, APTT < 1,5 x UNL
- Patients with obstruction of bile duct or gut must be drained before start of therapy
- Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- No sign of M1 disease
- No prior radiotherapy to abdominal cavity
- No pregnancy or breast-feeding. Fertile patients must use adequate contraceptives
- No sign of other severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)
- No prior chemotherapy for BTC
- No prior chemotherapy or other oncologic therapy within 12 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The overall and long term objectives are to improve outcome for patients with BTC – carcinomas of the gallbladder, intrahepatic, perihilar, or distal bile ducts. ;Secondary Objective: Not applicable;Primary end point(s): Primary objective is 2 year survival for all patients starting chemotherapy;Timepoint(s) of evaluation of this end point: 5-7 years after last treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Surgical morbidity and mortality<br>- Number of patients with progression during chemotherapy<br>- Number of patients with R0 resection<br>- Acute and late toxicity<br>- Search for predictive factors (tumour-markers);Timepoint(s) of evaluation of this end point: 10-15 years after last treatment